Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
NCT ID: NCT02422303
Last Updated: 2018-02-15
Study Results
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View full resultsBasic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2015-12-31
2016-09-30
Brief Summary
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Detailed Description
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Once the patient is consented they will be randomized to one of two groups. Every patient will receive an antianxiety medication Midazolam and a narcotic fentanyl prior to going to the operating room. Group A will receive ketamine 0.5mg/kg intravenous as part of their induction for general anesthesia. Group B will not receive ketamine as part of their anesthetic. All other induction drugs will be at the discretion of the anesthesiologist performing the anesthetic.
The patients will be seen by a separate anesthesia provider (who is blinded to the group the patient is in) and the results of the depression screening will be added to the patient's data sheet.
The patients will be followed again one week after their surgery either in their hospital room (if still hospitalized) or by phone. They will again be given the Goldberg Depression screen and the data will again be added to their data sheet.
Several times during the study and at its conclusion the data will be matched with the patients group in order to assess for adverse events such as suicidal ideations, nausea and vomiting. If adverse events are noted, the study design will be altered to take into account the adverse events.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ketamine Group
This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.
ketamine
Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.
No ketamine group
This group will not receive ketamine at induction of general anesthesia.
No interventions assigned to this group
Interventions
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ketamine
Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Bonny C Gillis, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology UTHSCSA
Locations
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University Hospital
San Antonio, Texas, United States
Countries
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References
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Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.
Naughton M, Clarke G, O'Leary OF, Cryan JF, Dinan TG. A review of ketamine in affective disorders: current evidence of clinical efficacy, limitations of use and pre-clinical evidence on proposed mechanisms of action. J Affect Disord. 2014 Mar;156:24-35. doi: 10.1016/j.jad.2013.11.014. Epub 2013 Dec 10.
Martinowich K, Jimenez DV, Zarate CA Jr, Manji HK. Rapid antidepressant effects: moving right along. Mol Psychiatry. 2013 Aug;18(8):856-63. doi: 10.1038/mp.2013.55. Epub 2013 May 21.
Other Identifiers
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HSC20150248H
Identifier Type: -
Identifier Source: org_study_id
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